2003
DOI: 10.1200/jco.2003.01.008
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An Intergroup Phase III Comparison of Standard Radiation Therapy and Two Schedules of Concurrent Chemoradiotherapy in Patients With Unresectable Squamous Cell Head and Neck Cancer

Abstract: The addition of concurrent high-dose, single-agent cisplatin to conventional single daily fractionated radiation significantly improves survival, although it also increases toxicity. The loss of efficacy resulting from split-course radiation was not offset by either multiagent chemotherapy or the possibility of midcourse surgery.

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Cited by 1,540 publications
(1,166 citation statements)
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References 31 publications
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“…Therefore, the present phase II study was designed to evaluate the efficacy and toxicity of capecitabine instead of 5-FU, a commonly used agent, in combination with cisplatin for concurrent chemoradiotherapy in patients with locally advanced SCCHN. In the current study, the clinical CR rate (78.4%), locoregional control rate (72.6% at 2-year), and progression-free survival rate (57.9% at 2 years) following treatment with the present regimen, which can be administered on an outpatient basis, were comparable with previous results reported for 5-FU and platinum-based concurrent chemoradiotherapy, although the follow-up period was relatively short to compare the survival rate directly (Calais et al, 1999;Adelstein et al, 2000Adelstein et al, , 2003. For example, concurrent chemotherapy with infusion of 5-FU and cisplatin arm achieved a CR rate of 49.4% and 3-year overall survival rate of 27% in a randomised study compared with concurrent chemoradiotherapy with radiation therapy alone (Adelstein et al, 2003).…”
Section: Discussionsupporting
confidence: 87%
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“…Therefore, the present phase II study was designed to evaluate the efficacy and toxicity of capecitabine instead of 5-FU, a commonly used agent, in combination with cisplatin for concurrent chemoradiotherapy in patients with locally advanced SCCHN. In the current study, the clinical CR rate (78.4%), locoregional control rate (72.6% at 2-year), and progression-free survival rate (57.9% at 2 years) following treatment with the present regimen, which can be administered on an outpatient basis, were comparable with previous results reported for 5-FU and platinum-based concurrent chemoradiotherapy, although the follow-up period was relatively short to compare the survival rate directly (Calais et al, 1999;Adelstein et al, 2000Adelstein et al, , 2003. For example, concurrent chemotherapy with infusion of 5-FU and cisplatin arm achieved a CR rate of 49.4% and 3-year overall survival rate of 27% in a randomised study compared with concurrent chemoradiotherapy with radiation therapy alone (Adelstein et al, 2003).…”
Section: Discussionsupporting
confidence: 87%
“…Meanwhile, grade 3 or 4 neutropenia occurred only in two patients (5.4%), plus grade 3 febrile neutropenia was observed in patient (2.7%) in the current study. These incidences of haematologic toxicities were significantly different from previous studies using 5-FU-containing regimens, where the incidence of grade 3 or 4 leukopenia was 29 -81% (Vokes et al, 2000;Adelstein et al, 2003). Recently, taxanes, such as paclitaxel and docetaxel, which exhibit activity against SCCHN, are being increasingly used for concurrent chemoradiotherapy to improve the treatment outcome (Kies et al, 2001;Tishler et al, 2002;Katori et al, 2004).…”
Section: Discussionmentioning
confidence: 67%
“…Trials have demonstrated a survival benefit for the addition of concurrent chemotherapy with the cost of increased treatment toxicity 1,2 .…”
Section: Introductionmentioning
confidence: 99%
“…Although this difference did not reach statistical significance, it becomes more critical when compared to established radiochemotherapy regimens. For example, in the case of a daily fractionated radiation, the total dose should not be less than 70 Gy (Adelstein et al, 2003). Therefore, the total dose of 66 Gy, which was used in the study must be viewed as insufficient.…”
Section: Sirmentioning
confidence: 99%